ORKAMBI

Vertex Pharmaceuticals Incorporated🇺🇸 United States

FDA Page

Effective Date: Mar 24, 2026
Approval ID: 3fc1c40e-cfac-47a1-9e1a-61ead3570600
Products: 5 registered
Version: 24

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015

Quick Stats

Total Products5

Labelers2

Label Sections42

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.